Arrangement, a loop-shaped support, a prosthetic heart valve and a method of repairing or replacing a native heart valve

ABSTRACT

The present disclosure relates to an arrangement, a loop-shaped support, a prosthetic heart valve and a method of repairing or replacing a native heart valve. With the method or the arrangement, leakage or regurgitation between a prosthetic heart valve and the surrounding valve tissue is prevented. In one embodiment, an arrangement for replacement or repair of a native heart valve is provided, which comprises a loop-shaped support  41  and a prosthetic heart valve  70  and wherein an outer segment  32  of the loop-shaped support  41  is positionable towards surrounding valve tissue of a native heart valve and wherein an outer surface  74  of the prosthetic heart valve  70  is positionable towards an inner segment  34  of the loop-shaped support  41  so as to prevent paravalvular leakage or regurgitation between the prosthetic heart valve  70  and the surrounding valve tissue of the native heart valve.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/405,286 filed May 7 2019, which is a continuation of U.S. patentapplication Ser. No. 15/275,903 filed Sep. 26, 2016, which is acontinuation of U.S. patent application Ser. No. 14/373,878 filed onJul. 22, 2014, (now U.S. Pat. No. 9,474,599 issued Oct. 25, 2016), whichis the U.S. National Phase application of and claims priority toInternational Patent Application No. PCT/EP2013/051366, InternationalFiling Date Jan. 24, 2013, which claims benefit of European ApplicationNo. EP12152348.4, filed Jan. 24, 2012; and U.S. Provisional ApplicationSer. No. 61/590,715, filed Jan. 25, 2012; all of which are incorporatedherein by reference in their entireties.

BACKGROUND OF THE INVENTION Field of the Invention

This disclosure pertains in general to the field of medical devices andmethods. More particularly, the disclosure relates to a medical devicefor improving the function of a heart valve, and in particular toreplacement or repair of a native heart valve.

Description of the Prior Art

In FIG. 1, a portion of the heart 12 is illustrated. The portioncomprises the mitral valve 18, and the left ventricle 14. The mitralvalve is at its boundary circumferenced by an annulus 20. The valve hastwo cusps or leaflets 22, 24. Each of these cusps or leaflets 22, 24 areconnected to a respective papillary muscle 27, 29 via their respectiveconnecting chordae 26, 28. In normal healthy individuals, the free edgesof the opposing leaflets 22, 24 will close the valve. However, for someindividuals the closure is not complete, which results in regurgitation,also called valvular insufficiency, i.e. a back flow of blood to theleft atrium and potentially increasing blood pressure in pulmonarycirculation making the heart less effective and with potentially severeconsequences for the patient. FIG. 2 illustrates a mitral valve 18, inwhich the leaflets 22, 24 do not close properly. This commonly occurswhen the annulus 20 becomes dilated. One surgical procedure to correctthis is to remove a portion of the leaflet 24 and stitch the cut edgestogether with one another. The procedure will pull back the annulus 20to a more normal position. However the strength of the leaflet 24 isaltered. Similar problems with a less effective heart function may occurif one or both leaflets 22, 24 are perforated to such an extent thatblood is flowing towards the left atrium, although the leaflets closeproperly.

In some conditions of degenerated heart function, the leaflets 22, 24 donot present a solid surface, as in a degenerative valve disease. Theleaflet could also be perforated, with one or several holes, where theblood can flow backwards into the atrium.

Another possibility is that the leaflet is ruptured, most commonly at anedge of a leaflet, resulting in an incomplete coaptation. In someconditions of degenerated heart function, the leaflets do not present asolid surface, e.g. degenerative valve disease. The leaflet could beperforated, with one or several holes, where the blood can flowbackwards into the atrium. Another possibility is that the leaflet isruptured, most commonly at an edge of a leaflet, resulting in anincomplete coaptation.

Similar problems may arise in other native heart valves, such as in anaortic valve, in a pulmonic valve or in a tricuspid valve.

Some or all of these deficiencies may be remedied by the insertion of aprosthetic heart valve. However, it may be difficult to fit theprosthetic heart valve tightly to the native heart valve and thus, theremay be a back-flow or leakage between the annulus or other surroundingvalve tissue and the prosthetic heart valve.

Hence, an arrangement and/or a method for replacement or repair of anative heart valve, in which there is no paravalvular leakage orregurgitation between a prosthetic heart valve and the surrounding valvetissue, would be advantageous.

Furthermore, for fastening of such a prosthetic heart valve, replacementflaps can be used. Such replacement flaps can be anchored atdysfunctional flaps of the native heart valve and thereby give radialsupporting force to the prosthetic heart valve, which is therefore alsoanchored. There are some prior art in this field, e.g. EP 1 994 913 A2;EP 1 469 797 BI; EP 1 259 195 BI; WO 2007/051620 A1; WO 2007/048529 A1;EP 1 980 220 A1; WO 01/64137 A1; EP 1 255 510 B3; and U.S. Pat. No.5,411,552 and W02008/058940 A 1. From W02008/058940 A 1, a device forimproving the function of a heart valve is known, which comprises afirst loop-shaped support, which is configured to abut a first side of aheart valve, and a first flange unit being connected to the firstloop-shaped support. The flange unit is configured to be arrangedagainst the annulus when the first loop-shaped support is abutting theheart valve.

However, for a device, such as the one described in W02008/058940 A1, itmay be advantageous to provide for a prosthetic valve, which ispositionable tightly towards a loop-shaped support.

Moreover, for a device, such as the one described in W02008/058940 A1,it may be advantageous to improve support of the positioning of aprosthetic heart valve inside the loop-shaped support.

In addition, for a device, such as the one described in W02008/058940A1, it may be advantageous to seal the area between the prosthetic heartvalve and a loop-shaped support.

SUMMARY OF THE INVENTION

Accordingly, embodiments of the present disclosure preferably seek tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing an arrangement, a loop-shaped support, aprosthetic heart valve and a method of repairing or replacing a nativeheart valve, according to the appended patent claims.

According to aspects of the disclosure, an arrangement, a loop-shapedsupport, a prosthetic heart valve and a method of repairing or replacinga native heart valve are disclosed, whereby leakage or regurgitationbetween a prosthetic heart valve and the surrounding valve tissue isprevented.

According to a first aspect of the disclosure, an arrangement forreplacement or repair of a native heart valve is provided. Thearrangement comprises a loop-shaped support; and a prosthetic heartvalve. An outer segment of the loop-shaped support is positionabletowards surrounding valve tissue of the native heart valve. Furthermore,an outer surface of the prosthetic heart valve is positionable towardsan inner segment of the loop-shaped support. The circumference of theloop-shaped support is substantially larger than a circumference of theprosthetic heart valve. The loop-shaped support is radially downsizeableto fit tightly around the prosthetic heart valve so as to seal the areabetween the prosthetic heart valve and the loop-shaped support. Therebyparavalvular leakage or regurgitation between the prosthetic heart valveand the surrounding valve tissue of the native heart valve is prevented.The native heart valve may be an aortic valve, a mitral valve, apulmonic valve or a tricuspid valve. Thus, an atrioventricular valveprosthesis can be used for one or several of an aortic valve, a mitralvalve, a pulmonic valve or a tricuspid valve.

According to a second aspect of the disclosure, a loop-shaped support isprovided. The loop-shaped support is intended to be used in anarrangement for replacement or repair of a native heart valve. It has aninner segment and an outer segment. The inner segment is positionabletowards a prosthetic heart valve and the outer segment is positionabletowards surrounding valve tissue of a native heart valve. Thecircumference of the loop-shaped support is substantially larger than acircumference of the prosthetic heart valve. The loop-shaped support isradially downsizeable to fit tightly around the prosthetic heart valveso as to seal the area between the prosthetic heart valve and theloop-shaped support. Thereby paravalvular leakage or regurgitationbetween the prosthetic heart valve and the surrounding valve tissue isprevented.

According to a third aspect of the disclosure, a prosthetic heart valveis provided. The prosthetic heart valve is intended to be used in anarrangement for replacement or repair of a native heart valve. Theprosthetic heart valve has an outer surface being positionable towardsan inner segment of a loop-shaped support. The circumference of theloop-shaped support is substantially larger than a circumference of theprosthetic heart valve. The loop-shaped support is radially downsizeableto fit tightly around the prosthetic heart valve so as to seal the areabetween the prosthetic heart valve and the loop-shaped support. Therebyparavalvular leakage or regurgitation between the prosthetic heart valveand surrounding valve tissue is prevented.

According to a fourth aspect of the disclosure, a method of repairing orreplacing a native heart valve is provided. The method comprisespositioning of a loop-shaped support at an annulus of a native heartvalve. The loop-shaped support comprises an inner segment and an outersegment. The outer segment of the loop-shaped support is positionedtowards the annulus or surrounding valve tissue. Thereafter, aprosthetic heart valve is advanced towards the loop-shaped support. Theprosthetic heart valve can be advanced partly through the loop-shapedsupport. An outer surface of the prosthetic heart valve is positionedtowards the inner segment of the loop-shaped support. Thereby,paravalvular leakage or regurgitation between the prosthetic heart valveand the annulus and/or the surrounding valve tissue of the native heartvalve is prevented.

Further embodiments of the disclosure are defined in the dependentclaims, wherein features for the second and subsequent aspects of thedisclosure are as for the first aspect mutatis mutandis.

Some embodiments of the disclosure provide for replacement or repair ofa native heart valve.

Some embodiments of the disclosure provide for prevention ofparavalvular leakage or regurgitation between the prosthetic heart valveand the surrounding valve tissue of the native heart valve.

Some embodiments of the disclosure also provide for sealing of the areabetween the prosthetic heart valve and the loop-shaped support tofurther improve prevention of paravalvular leakage or regurgitation.

Some embodiments of the disclosure also provide for that both the areabetween the surrounding valve tissue and the flange unit/loop-shapedsupport and the area between the prosthetic heart valve and the flangeunit/loop-shaped support are sealed.

Some embodiments of the disclosure also provide for fixation of theloop-shaped support and/or the prosthetic heart valve.

Some embodiments of the disclosure also provide for improved stability.

Some embodiments of the disclosure also provide for prevention ofunwanted loop-shaped support and prosthetic heart valve movement.

Some embodiments of the disclosure also provide for that valve tissuewill be trapped between the supports to fixate a desired shape of thevalve.

Some embodiments of the disclosure also facilitate delivery of aprosthetic heart valve.

Some embodiments of the disclosure also provide for enabling minimallyinvasive and percutaneous replacement or repair of cardiac valves.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe disclosure are capable of will be apparent and elucidated from thefollowing description of embodiments of the present disclosure,reference being made to the accompanying drawings, in which

FIG. 1 is a cross-sectional view of the left ventricle of the heart;

FIG. 2 is a lateral view of the mitral valve;

FIG. 3a is a top view of a loop-shaped support;

FIG. 3b is a lateral view of a helically shaped and loop-shaped support;

FIG. 4 is a cross-sectional view of the loop-shaped support;

FIG. 5 is a lateral view of a loop-shaped support with a flange unit;

FIG. 6 is a lateral view of a stented prosthetic heart valve;

FIG. 7 is a lateral view of a stented prosthetic heart valve positionedinside a loop-shaped support;

FIG. 8 is a lateral view of a loop-shaped support positioned at thetarget site before the stented prosthetic heart valve has beenpositioned inside the loop-shaped support; and

FIG. 9 is a view from above at an angle of a loop-shaped supportequipped with fingers.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Specific embodiments of the disclosure will now be described withreference to the accompanying drawings. This disclosure may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the disclosure. In the drawings, like numbers refer to like elements.

The following description focuses on an embodiment of the presentdisclosure applicable to a native heart valve and in particular to amitral valve. However, it will be appreciated that the disclosure is notlimited to this application but may be applied to many other heartvalves including for example an aortic valve, a pulmonic valve or atricuspid valve.

In an embodiment of the disclosure according to FIG. 3a , theloop-shaped support 41 is round and forms a circle. The loop-shapedsupport 41 has an outer segment 32 and an inner segment 34. The outersegment 32 may on the outer edge of the loop-shaped support 41 bethreaded so as to provide a possibility to better fixate the loop-shapedsupport to the surrounding valve tissue and thus prevent the loop-shapedsupport from sliding out of its position. As can be seen from FIG. 3a ,the loop-shaped support 41 has a top portion 36 located between theouter segment 32 and the inner segment 34. On the opposite side of thetop portion, there is a bottom portion (not seen in the figure).

Another loop-shaped support 41 according to one embodiment of thepresent disclosure is shown in FIGS. 3b and 4. The loop-shaped support41 comprises a first and a second section 42, 44.

As used herein, the term “loop-shaped” should be construed as a curvedshape that may be closed, as at least a part of a ring with e.g. acircular, elliptic, or D-shaped form or any other closed form which mayfit the shape of the valve annulus. The term “loop-shaped” also includesa curved shape that is open forming an arcuate shape, such as a C-shapeor U-shape, which includes an angular turn of at least 180° such thatthe support may abut valve tissue along a major part of the annularvalve shape. The term “loop-shaped” also includes a curved shapeoverlapping itself to form a portion of a coil or helical structure.Such a helical structure may comprise a first part to be placed on theatrial side of the native heart valve and a second part to be placed onthe ventricular side of the native heart valve. The first part may havea diameter, which is larger than a diameter of the second part. Ahelical loop-shaped support or helical support rings may also be usedfor anchoring of occlusion devices, such as occluders for closing atrialseptal defects.

The term “loop-shaped” also includes three dimensional curves.

The loop shape of at least a part of at least one of the sections 42, 44may also in some embodiments be patient configured. The shape may bedesigned specifically to an anatomy of a patient. The patient specificloop shape may be virtually derived from 3D patient data, e.g. acquiredby image modalities, such as Magnetic Resonance (MR) or ComputerTomography (CT) Imaging.

In U.S. Pat. Nos. 6,419,696, 6,730,121, 6,964,684, and WO 2006/091163,which are assigned to the same applicant as the present disclosure andincorporated by reference herein in their entirety for all purposes,devices are disclosed for repairing and replacing a heart valve invarious embodiments. The devices include at least first and secondsupport rings connected together in loop-shaped configurations to abutopposite sides of a valve annulus. A replacement valve may be secured tothe loop-shaped devices.

The first section 42 may be continuous and/or integral with the secondsection 44 such that the sections 42, 44 assume a coiled configurationin the form of a spiral or key ring-type configuration with two loops.

The second section 44 may have an outer boundary or extent which isgreater in relation to the outer boundary of the first section 42. Thesections 42, 44 may in an embodiment have corresponding shapes with thesecond section 44 being in larger scale than the first section 42. Thisis advantageous for creating a pinch of the valve tissue between thefirst 42 and second sections 44.

An end 45 of the second section 44, which will lead the coil duringinsertion of the device at the valve, may in an embodiment have agreater pitch than the rest of the coil. This implies that the leadingend 45 of the coil during rotation into position in the valve willproject from immediate contact with the valve tissue and, therefore, therisk that the coil is caught by the chords is diminished.

The loop-shaped support 41 is shown in cross-section in FIG. 4. Theloop-shaped support 41 has in an embodiment at least partly a roundcross-sectional shape. In other embodiments, the cross-section of theloop-shaped support 41 may be substantially flat, oval, flattened and/orhave flattened edges. As an example, the loop-shaped support 41 may inone embodiment have an outer segment 32, which is substantially round orrounded and an inner segment 34, which is substantially flat orflattened. A better fit to a prosthetic heart valve may be provided bythe use of a flat or flattened inner segment 34. Thereby, the sealing ofthe area between the prosthetic heart valve and the loop-shaped supportand the prevention of paravalvular leakage is further improved.

In embodiments, the opposed surfaces 46 thus provide a pinch to trapvalve tissue there between. A round cross-section is also advantageousin creating a pinch of the valve tissue which will not harm the leafletsin their movement during normal heart action.

The second section 44 is slightly displaced radially with respect to thefirst section 42. This implies that the first and second sections 42, 44are not arranged directly on top of each other in some embodiments. Thepinch between the first 42 and second sections 44 is therefore notsharply defined in a radial direction of the valve. This implies that apinching force between the sections 42, 44 is not focused to a specificradial position of the valve. As a result, the pinching force does notaffect the movement of the leaflets during normal heart action and thereis a diminished risk of rupture in the leaflets at the pinch.

The sections 42, 44 may in some embodiments be interrelated in such amanner that the outer boundary of the first section 42 has a diametercorresponding to a line through the centre of the second section 44.Thus, the sections 42, 44 may overlap somewhat such that tissue is notallowed to move through the pinch and the shape of the valve ismaintained advantageously.

Further, the cross-section of the sections 42, 44 is substantiallyround, which also gives a soft contact between the sections and thevalve tissue to further diminish the risk of rupture in the leaflets.

The loop-shaped support 41 may be formed from a core of a rigidmaterial, such as a metal, e.g. titanium, or plastic. The rigid materialmay provide a passive spring function, so that the loops of the coil maybe forced a small distance away from each other but will flex backtowards each other when the force is released. The core of theloop-shaped support 41 may be coated by a softer layer, such as atextile.

The loop-shaped support 41 may alternatively be formed from a shapememory material. The loop-shaped support 41 will then assume a desired,programmed shape, when e.g. heated to a specific temperature. Thisallows the loop-shaped support 41 to be compressed or straightened to aform better suited for deliverance and/or during insertion and to assumea spiral or helical shape when inserted at the heart valve. Also aflange unit 50 may be made of such a shape memory material, e.g. toprovide a first, delivery shape and a second shape assumed after beingdelivered.

Now turning to FIG. 5, an embodiment of the loop-shaped support 41 isdisclosed. The loop-shaped support 41 comprises a flange unit 50 beingconnected to the first section 42. The flange unit 50 has in anembodiment a continuous extension along the periphery of the firstsection 42.

In some embodiments, the flange unit 50 may be integral with at least aportion of the loop-shaped support 41.

In some embodiments the flange unit 50 is made of a tube shaped flexiblematerial being passed onto the first section 42, whereby a loosesubstantially co-axial connection between the loop-shaped support 41 andthe flange unit 50 is achieved. The connection may also be fixed orrigid. The flexible material may by way of example be a fabric or wovenstructure made of Polyethylene (PE) or polytetrafluoroethylene (PTFE). Afabric has the advantage that it presents a rough, holed or poroussurface enhancing growth of and overgrowth of endothelia. Further, afabric is easily penetrated by sutures or clips. In addition, theflexible material admits the flange unit 50 to be conformed to theannulus. It also admits the flange unit 50 to be conformed to aprosthetic heart valve 70.

The flange unit 50 does in the disclosed embodiment form a flangesurface extending downwards out from the body. More precisely the flangeunit 50 forms in some embodiments an angle α to a horizontal, diametricplane formed by the loop-shaped support. The angle α is approximatelybetween 30-60°, such as 40-50° to the diametric plane. Such angleimproves the visibility during insertion of the loop-shaped support. Insome embodiments, improved visibility may be provided during insertionof the loop-shaped support, whereupon the flange unit 50 changes shapeto a position facilitating fixation thereof to surrounding tissue. Thus,medical procedures for heart valve repair and/or replacement may bespeeded up considerably.

In a practical embodiment the flange surface has a width in the range ofapproximately 2-4 mm, such as 2.5-3.5 mm. The width of the flangeradially outwards allows an indication for the surgeon of the area inwhich sutures or clips should be positioned when fixating theloop-shaped support to the annulus. Initially, before inserted into theheart valve, the flange surface extends downwardly. When positioned inthe atrial side of the heart valve, the loop-shaped support 41 will bearranged abutting the annulus, whereby the flange unit 50 will beconformed to the annulus, changing its angle from extending downwardlyto extending upwardly. This ability to conform is a combination of theflexibility of the (fabric) material and the width of the flange unit50.

On its outer periphery, the flange unit 50 may comprise a reinforcingelement 65, which is schematically illustrated in FIG. 5. Suchreinforcing element may by way of example have the form of a thread or abead.

In an embodiment according to FIG. 6, a prosthetic heart valve 70comprises a stent or stent frame 52 and a valve structure 54. The stentframe 52 is generally constructed so as to be self-expandable from acompressed arrangement to the normal, expanded arrangement (shown inFIG. 6). In other embodiments, the stent frame 52 is expandable to theexpanded arrangement by a separate device, e.g., a balloon internallylocated within the stent frame 52. The valve structure 54 is assembledto the stent frame 52 and provides two or more leaflets 56. Theprosthetic heart valve 70 may also be fastened as described in e.g. U.S.Pat. No. 5,411,552 A or EP1255510 B. As an example, a mitral valve or atricuspid valve from e.g. a pig can be fastened to the loop-shapedsupport by sewing. The prosthetic heart valve 70 is configured forreplacing or repairing a native mitral valve. Alternatively, othershapes are also envisioned, adapted to the specific anatomy of the valveto be repaired, e.g., stented prosthetic heart valves in accordance withthe present disclosure can be shaped and/or sized for replacing a nativeaortic, pulmonic, or tricuspid valve. In one embodiment, the valvestructure 54 extends less than the entire length of the stent frame 52,but in other embodiments it can extend along an entirety, or a nearentirety, of a length of the stent frame 52. A wide variety of otherconstructions are also acceptable and within the scope of the presentdisclosure. For example, the stent frame 52 can have a more cylindricalshape in the normal, expanded arrangement.

A further embodiment of the disclosure is illustrated in FIG. 7. In FIG.7, the prosthetic heart valve 70 is shown in an arrangement forreplacement or repair of a native heart valve, together with aloop-shaped support 41. An outer segment 32 of the loop-shaped support41 is positionable towards surrounding valve tissue of a native heartvalve. Furthermore, as can be seen from the figure, an outer surface 74of the prosthetic heart valve 70 is positionable towards an innersegment 34 of the loop-shaped support 41 so as to prevent paravalvularleakage or regurgitation between the prosthetic heart valve 70 and thesurrounding valve tissue of the native heart valve. The inner segment 34is adapted for receiving a radially expandable prosthetic heart valve70, and the loop-shaped support 41 is radially rigid, i.e. rigid in aradial direction, for preventing an expansion of the prosthetic heartvalve 70 beyond the inner segment 34. However, the expandable prostheticheart valve 70 will expand as far as it can in order to reach its normalexpanded state, when it is expanded during delivery. Thus, the outersurface 74 of the prosthetic heart valve 70 will be tightly positionedtowards an inner segment 34 of the loop-shaped support 41. Thereby thearea between the prosthetic heart valve 70 and the loop-shaped support41 is sealed. In FIG. 7, the loop-shaped support 41 is depicted as around circle-shaped support having no free end. However, in otherembodiments, the loop-shaped support 41 may be helically or coil-shapedas depicted in FIGS. 3b -5.

Since the flange unit 50 provides for a sealing surface against theannulus allowing prevention of backflow of blood from the ventricle tothe atrial side, both the area between the surrounding valve tissue andthe flange unit 50/loop-shaped support 41 and the area between theprosthetic heart valve 70 and the flange unit 50/loop-shaped support 41are sealed. The flange unit 50 may also form a flange surface on bothsides of the annulus or heart valve, which surface may provide forfixation of loop-shaped support 41 and/or prosthetic heart valve 70.

FIG. 8 shows a loop-shaped support 41 positioned at the target sitebefore the stented prosthetic heart valve 70 has been positioned insidethe loop-shaped support 41. In this embodiment, the target site is anative heart valve, such as a mitral valve 18 and the loop-shapedsupport 41 is helically shaped. Also native leaflets 22, 24 andsurrounding valve tissue 80 can be seen in the figure. The first andsecond sections 42, 44 are situated on either side of the valve, sincethe second section 44 has been rotated or screwed through the valve intoits position. If needed, the loop-shaped support 41 may be furthersecured to the valve by clips, sutures or other suitable means.

In one embodiment, one of the sections, e.g. the first section 42extends further away from the native heart valve than the other section,e.g. the second section 44, so as to provide a larger sealing areatowards the prosthetic heart valve 70. Normally the loop-shaped support41 is positioned at the target site first and first thereafter theprosthetic heart valve 70 is positioned at the target site. However, itis also possible that the prosthetic heart valve 70 is positioned at thetarget site before introduction of the loop-shaped support 41. When theloop-shaped support 41 has been positioned at the target site, thestented prosthetic heart valve 70 is fitted to the loop-shaped support41 by first positioning the stented prosthetic heart valve 70 inside theloop-shaped support 41 and then expanding the stented prosthetic heartvalve 70 to its normal expanded state. Thus, the area between theprosthetic heart valve 70 and the loop-shaped support 41 is sealed.Thereby paravalvular leakage or regurgitation between the prostheticheart valve 50 and surrounding valve tissue is prevented.

A further embodiment is depicted in FIG. 9. Instead or in addition tohaving a section extending further away from the native heart valve, theloop-shaped support 41 may have fingers 90, extensions, crown-shapedextensions or struts connected to a top portion 36 or a bottom portionof the loop-shaped support 41 and pointing in a direction away from thenative heart valve when the loop-shaped support 41 has been placed inits operational position, which direction is substantially parallel witha longitudinal centre axis of the loop-shaped support 41. These fingersmay support the positioning of a prosthetic heart valve inside theloop-shaped support 41 and eliminate or reduce tilting movement inrelation to a plane being in parallel with a mitral plane, i.e. a planehaving the atrium on one side and the ventricle on the other side. Thefingers 90 may be slightly flexible so that they can better adapt to theshape of a prosthetic heart valve. As an alternative, the loop-shapedsupport 41 may have fingers 90 extending in both directions pointingaway from the native heart valve, i.e. in a direction from the nativeheart valve towards the atrium and in a direction from the native heartvalve towards the ventricle, when the loop-shaped support has beenplaced in its operational position. By the use of fingers 90 in bothdirections, the positioning of a prosthetic heart valve inside theloop-shaped support may be further supported and thus, a tiltingmovement may be further reduced. In one embodiment, the loop-shapedsupport 41 has a top portion 36 and a bottom portion. At least one ofthe top 36 and bottom portions is connected to at least one crown-shapedportion and a top of the at least one crown-shaped portion is extendingsubstantially perpendicularly towards the atrium or the ventricle sothat the positioning of a prosthetic heart valve inside the loop-shapedsupport 41 is supported by the at least one crown-shaped portion. Atilting movement in relation to a plane being in parallel with a mitralplane may also be eliminated or reduced.

In some embodiments the prosthetic heart valve 70 is rigid. The outersurface 74 of the prosthetic heart valve 70 is tightly positionedtowards the inner segment 34 of the loop-shaped support (41), so as toseal the area between the prosthetic heart valve 70 and the loop-shapedsupport 41. The loop-shaped support 41 is in these embodiments somewhatflexible to compensate for the rigidity of the prosthetic heart valve70.

In some embodiments a circumference of the loop-shaped support 41 issubstantially larger than a circumference of the prosthetic heart valve70. The loop-shaped support 41 is then radially downsizeable to fittightly around the prosthetic heart valve 70 so as to seal the areabetween the prosthetic heart valve 70 and the loop-shaped support 41.The loop-shaped support, which has a circumference which issubstantially larger than the circumference of the prosthetic heartvalve 70 may be downsizeable, e.g. by first assuming a first shape andthen after positioning assuming a second shape, which may be obtained bya change of shape, such as a change of shape of a shape memory material.By such a change in shape, i.e. a change from oversized to a size thatis just right, the loop-shaped support 41 may fit tightly around theprosthetic heart valve 70 so as to seal the area between the prostheticheart valve 70 and the loop-shaped support 41. When the loop-shapedsupport 41 has assumed a size that is just right to fit tightly aroundthe prosthetic heart valve 70, a force which is appropriate for sealingthe area between the prosthetic heart valve 70 and the annuloplasty ring41, but not large enough to cause any damage to the annuloplasty ring 41or the native valve is exerted on the annuloplasty ring 41.

Another situation when valve leakage, i.e. regurgitation or valvularinsufficiency may occur is during catheter-based delivery. Duringdelivery through a catheter, e.g. for replacement or repair of cardiacvalves, such as the mitral valve, there is a chance that the catheterdelivered valve may cause leakage or regurgitation, since thesurrounding tissue is non-rigid. The soft tissue in the annulus regionis thus not tightly holding the valve in its desired place. Thesurrounding soft tissue may over extend and due to increasing bloodpressure during the heart cycle, an outer by-pass blood flow may occurat the outer circumference of the valve or its casing or anchoringstent. In such a situation, a loop-shaped support 41 may be beneficialfor preventing paravalvular leakage or regurgitation.

In some embodiments, the fingers 90 are slightly offset from theloop-shaped support 41 in a radial direction, so that there is a gapbetween the outer segment 32 of the loop-shaped support 41 and thefingers 90. The fingers 90 may then be attached to only a portion of thefull axial length of the loop-shaped support 41 so that a gap is formedbetween the loop-shaped support and the fingers 90 for a part of theloop-shaped support in an axial direction. In one embodiment, thefingers are attached to the loop-shaped support for at least half of thefull axial length of the loop-shaped support 41. By the use of fingers90, which are located slightly offset from the loop-shaped support,biological material, e.g. natural remaining valvular tissue from thenative heart valve, such as dysfunctional flaps and/or chordaes, can betrapped in the gap between the loop-shaped support 41 and the fingers90. Thereby, the positioning of the loop-shaped support 41 and/or theprosthetic heart valve 70 is further stabilized and thereforeparavalvular leakage is further prevented.

Also when metal is put against metal at a target site, such as at amitral valve, there is no good adherence. Thus, there is a possibilityof leakage or regurgitation between two metal parts, especially betweentwo round or cylinder-formed metal parts or when one metal part is to bepositioned inside another metal part. In one embodiment, a loop-shapedsupport 41 may be positioned in-between the metal parts at a targetsite, such as the mitral valve, so as to provide good adherence and toseal the area between the two metal parts, so that no leakage will occurat the target valve.

The arrangement, the loop-shaped support 41 and/or the prosthetic heartvalve 70 can be implanted via a catheter. This may be performedtransepitally, transapically or transvascularly, e.g. retroversily viathe aorta.

Furthermore, other means, such as hooks, can be used for anchoring ofthe arrangement, the loop-shaped support 41 and/or the prosthetic heartvalve 70. In one embodiment, the prosthetic heart valve 70 is anchoredwith anchor elements. Thus, a method of anchoring a prosthetic heartvalve 70 in a patient's heart is provided. The method comprisesanchoring the prosthetic heart valve 70 on the ventricular side withthree or more, preferably four, anchor elements integrated with theprosthetic heart valve 70 situated on the ventricle side of theprosthetic heart valve 70, extending outwards from the prosthetic heartvalve 70 and distributed equally around the prosthetic heart valve 70.The method further comprises anchoring the prosthetic heart valve 70 onthe atrial side with three or more, preferably four, anchor elementsintegrated with the prosthetic heart valve 70 situated on the atriumside of the prosthetic heart valve 70, extending outwards from theprosthetic heart valve 70 and distributed equally around the prostheticheart valve 70. By the use of this method, the prosthetic heart valve 70is further stabilized in its position at the target site.

The present disclosure has been described above with reference tospecific embodiments. However, other embodiments than the abovedescribed are equally possible within the scope of the disclosure.Different method steps than those described above, may be providedwithin the scope of the disclosure. The different features and steps ofthe disclosure may be combined in other combinations than thosedescribed. The scope of the disclosure is only limited by the appendedpatent claims. More generally, those skilled in the art will readilyappreciate that all parameters, dimensions, materials, andconfigurations described herein are meant to be exemplary and that theactual parameters, dimensions, materials, and/or configurations willdepend upon the specific application or applications for which theteachings of the present disclosure is/are used.

The invention claimed is:
 1. A prosthetic implant for replacing a nativeheart valve, comprising: a prosthetic heart valve construct comprising:three leaflets; a distal inflow end; a proximal outflow end; aballoon-expandable stent positioned to extend distally below the inflowend, the balloon-expandable stent configured to take a first positionwith a first diameter and expand by the balloon to a second positionwith a second diameter; a closed, loop-shaped support structure havingno free end fastened to the balloon-expandable stent and positionedcoaxial with the prosthetic heart valve construct along a common axis,the loop-shaped support further comprising inner and outer surfaces anda radially extending flange, the inner surface extendingcircumferentially about a proximal portion of the balloon-expandablestent, the outer surface being configured to be positioned againsttissue of the native heart so as to seat the prosthetic implant foranchoring within the patient's native heart, the loop-shaped supportstructure having a loop diameter that is smaller than the seconddiameter; a plurality of struts extending proximally above theloop-shaped support; and three anchoring elements positioned equidistantfrom each other and distally below the valve leaflets.
 2. The prostheticimplant of claim 1, wherein the flange is tube-shaped.
 3. The prostheticimplant of claim 2, wherein the flange includes fabric configured to bepenetrated by one or more sutures for anchoring the flange to hearttissue.
 4. The prosthetic implant of claim 3, wherein the flange isconnected co-axially to the loop-shaped support structure.
 5. Theprosthetic implant of claim 3, wherein the flange is positionedproximally above the leaflets.
 6. The prosthetic implant of claim 3,wherein the flange is configured to take a first shape prior toimplantation and a second shape upon implantation so as to facilitatefixation to surrounding tissue.
 7. The prosthetic implant of claim 6,wherein the first shape is configured so that a surface of the flange isoriented downwardly relative to the prosthetic heart valve construct. 8.The prosthetic implant of claim 3, wherein the flange is configured toextend radially outwards from the prosthetic heart valve so as to, uponimplantation, indicate an area for suture insertion into native hearttissue.
 9. The prosthetic implant of claim 3, wherein the flange has awidth in the range of 2-4 mm.
 10. The prosthetic implant of claim 3,wherein the stent comprises a cylindrical frame and the prosthetic heartvalve structure is positioned inside the balloon expandable stent. 11.The prosthetic implant of claim 3, wherein the loop-shaped supportstructure is radially downsize-able to fit tightly around the prostheticvalve, so as to seal space between prosthetic heart valve construct andthe looped shaped support.
 12. The prosthetic implant of claim 3,wherein the looped shaped support is circular.
 13. The prostheticimplant of claim 3, wherein the prosthetic heart valve construct isconfigured for aortic valve replacement.
 14. The prosthetic implant ofclaim 13, wherein the anchoring elements are integrated with theprosthetic heart valve construct.
 15. The prosthetic implant of claim14, wherein the anchoring elements include a plurality of hooks.
 16. Theprosthetic implant of claim 3, wherein the struts extend parallel to theaxis.
 17. The prosthetic implant of claim 3, wherein a gap is formedbetween the struts and the loop-shaped support.
 18. The prostheticimplant of claim 17, wherein the struts are offset radially from theloop-shaped support.
 19. The prosthetic implant of claim 17, wherein thestruts comprise first and second sets of struts configured so that, whenthe implant is implanted, the first set of struts extends proximallyaway from the native heart tissue and the second set of struts pointsdistally away from the from the native heart tissue.
 20. The prostheticimplant of claim 3, wherein the loop-shaped support is connected to acrown-shaped portion.
 21. The prosthetic implant of claim 1, whereinsaid loop-shaped support structure is radially downsizeable.